FDA 510(k) Applications for Medical Device Product Code: JMM (Column Chromatography & Color Development, Hydroxyproline)

FDA 510(k) Applications for Medical Device Product Code "JMM"
(Column Chromatography & Color Development, Hydroxyproline)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K972580	BAYER CORP.	DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	09/22/1997
K963251	CIBA CORNING DIAGNOSTICS CORP.	CIBA CORNING ACS;180 DPD ASSAY	10/15/1996
K972788	DEVICES AND DIAGNOSTICS CONSULTING GROUP	CROSSLAPS ELISA	12/22/1998
K971312	DIAGNOSTIC PRODUCTS CORP.	IMMULITE PYRILINKS-D	05/27/1997
K980833	DIAGNOSTIC PRODUCTS CORP.	IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5	05/01/1998
K960171	DIAGNOSTIC SYSTEMS LABORATORIES, INC.	ACTIVE CROSSLAPS ELISA	03/28/1996
K974260	METRA BIOSYSTEMS, INC.	PYRILINKS-D ASSAY KIT	01/26/1998
K981364	METRA BIOSYSTEMS, INC.	PYRILINKS-D ASSAY KIT	08/13/1998
K992997	METRIKA, INC.	OSTEOMARK NTX POC	11/09/1999
K983674	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS	01/29/1999
K990843	OSTEOMETER BIOTECH A/S	SERUM CROSSLAPS ONE STEP ELISA	07/09/1999
K961562	OSTEX INTL., INC.	OSTEOMARK	07/11/1996
K980518	OSTEX INTL., INC.	OSTEOMARK	03/06/1998
K011052	OSTEX INTL., INC.	OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE	07/30/2001
K983457	OSTEX INTL., INC.	OSTEOMARK NTX SERUM EIA	02/02/1999
K993706	ROCHE DIAGNOSTICS CORP.	ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY	07/24/2000